New study indicates laparoscopic hysterectomy with morcellation may be safer than abdominal procedure

March 24, 2015

Researchers from the University of North Carolina at Chapel Hill have found that abdominal surgery is riskier than laparoscopic hysterectomy with morcellation in premenopausal women undergoing surgery for presumed uterine fibroids.

The study was published online March 24 in the American Journal of Obstetrics & Gynecology. Researchers examined quality of life, short- and long-term complications and overall mortality and found that abdominal surgery carries a higher risk of decreased quality of life, surgical complications and death.

Dr. Stephanie Wheeler

Stephanie Wheeler, PhD, MPH, assistant professor, health policy and management, at the UNC-Chapel Hill Gillings School of Global Public Health, is a co-author and the study’s senior analyst. “One of the most exciting aspects of this work, from my perspective, was the opportunity to use my technical skills to partner with outstanding clinical colleagues in surgery and gynecologic oncology,” she said.

Hysterectomy is the most common gynecologic procedure performed on non-pregnant women in the United States, with diagnosis of uterine fibroids (leiomyomata) accounting for many of these procedures. Minimally invasive laparoscopic surgery is being used more frequently as treatment because of its many advantages, including less pain and shorter length of hospital stay.

In some cases, however, the uterus cannot be removed without morcellation, a process that cuts the uterus into pieces so it can fit through small incisions. Morcellation has come under scrutiny in recent years because of concerns that if an undetected malignancy (leiomyosarcoma) is present, it may be dispersed into the pelvis and abdomen during morcellation, resulting in the spread of cancer and increased mortality. This concern resulted in an FDA notification that discouraged morcellation during hysterectomy.

Given the rarity of leiomyosarcoma, a randomized trial comparing mortality after different types of hysterectomy is not feasible. Consequently, the UNC-Chapel Hill researchers used decision-tree analysis, which compared the probable morbidity and mortality outcomes associated with abdominal surgery versus laparoscopy with morcellation at the population level.

“Decision models are especially useful when it is impractical, infeasible or unethical to conduct a randomized controlled trial or to follow populations prospectively for many years to observe rare outcomes like leiomyosarcoma or hysterectomy-related death,” Wheeler explained. “Simulation modeling, therefore, is especially well suited to assessing the comparative effectiveness of alternative procedural options in this setting. These models not only incorporate a range of different potential clinical events or outcomes of interest, but also allow researchers to accumulate, synthesize and extend observational and experimental data in a meaningful way to project outcomes and to test uncertainty in model input parameters.”

Researchers used results from published, peer-reviewed studies of the highest quality and most recent evidence to inform the selection of model inputs. Using a hypothetical cohort of 100,000 women over a five-year period, the investigators found that, while there would be more deaths from malignant leiomyosarcoma with laparoscopic surgery (98 vs. 103 per 100,000), there were more hysterectomy-related deaths from other causes, such as blood clots after surgery, with the abdominal procedure (32 vs. 12 per 100,000). These results showed a higher overall probability of death with abdominal hysterectomy compared to laparoscopic surgery with morcellation.

Sensitivity analyses assessed the robustness of the assumptions in the decision model, including surgical complications, the probability of leiomyosarcoma and probability of death from hysterectomy. The range of clinical outcomes, such as transfusion and wound infection, was evaluated by varying the input for each clinical event to its minimum and maximum.

Ingrid Nygaard, MD, editor-in-chief for gynecology of the American Journal of Obstetrics & Gynecology and professor of obstetrics and gynecology at the University of Utah, commented that, “No decision analysis is ever the ‘final word.’ The one in this month’s journal is no different. New data will continue to be added to the literature and the conclusions might stand as they are or change. But, most importantly, these findings remind us to keep the big picture in mind, to balance risks and benefits of different procedures and to work vigilantly to decrease the impact of risks to the extent possible.”

Wheeler added, “Our findings hold promise to better inform surgical decision-making among the approximately 200,000 women undergoing hysterectomies for presumed benign fibroids each year in the U.S.”